Regulatory Affairs Lead
Our mission at GSK is to improve the quality of lives by enabling people to do more, feel better and live longer. We recognise this starts with our own highly talented team and are committed to supporting, rewarding & developing our employees within a safe, supportive and inspiring work place.
Reporting into the Head of Regulatory Affairs (AU & NZ), this is a varied role that will see you engaging with a broad range of external and internal stakeholders in the GSK global and regional networks. As a critical member of our highly engaged and high achieving Regulatory Affairs team you will proactively monitor and shape the external environment to develop a positive regulatory environment that aligns with GSK's strategic business plans.
Your responsibilities will be broad and will include:
• Providing leadership, coaching and training support for the Regulatory Affairs team to impart your knowledge of best practice methodology and processes and to build technical and functional capability.
• The preparation, submission and tracking of accurate and timely regulatory applications.
• Assisting with the development and implementation of global GSK regulatory strategy.
• The management of maintenance of registered products ensuring product compliance.
• Working closely with local brand teams and global groups to proactively manage and where appropriate create, the response to all regulatory questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe.
• To provide input and expertise to assist medical, commercial, market access and marketing teams with new product initiatives and activities.
To be successful in this role you will have:
• A degree in pharmacy, chemistry, immunology or pharmacology with a strong preference for post graduate studies.
• First-hand experience with major regulatory submissions in Australia essential (NZ experience desirable).
• Therapeutic/scientific experience in one or several of the following: vaccines; respiratory; HIV; oncology
• Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry specifically for prescription rather than generic medicines.
• Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders.
• Excellent time management and prioritisation skills
• Strong analytical skills, excellent attention to detail and a commitment for compliance processes.
• Ability to think strategically and innovatively for resolution of regulatory issues.
• People management skills desirable
This role represents a great opportunity to work in an innovative global pharmaceutical company within a close-knit and engaged team working on a large pipeline of prescription products.
A degree in pharmacy, chemistry, immunology or pharmacology.
Strong preference for post graduate studies.
GlaxoSmithKline (GSK) is an innovative global leader in pharmaceutical research and development with a long and proud history in Australia. Our Australian, Melbourne-based business consists of both Pharmaceuticals and Vaccines.
You may apply for this position online by selecting the Apply now button.
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